82 
Newman, .Stuart A.. Professor. Department of Biological Sciences, State 
University of New York at Albany, November 20, 1977 
Sinsheimer, Robert, Chancellor, University of California at Santa Cruz. 
December 5. 1977 
Communications from : 
Burris, Robert H.. Professor of Agricultural Biochemistry, and Waelaw 
; Szvbalski, Professor of Oncology, University of Wisconsin, December 2. 
1977 
Cohen. Stanley X.. Professor of Medicine and Genetics, Stanford University 
Medical Center. October 27, 1977 
Hess, Eugene L., Executive Director, Federation of American Societies for 
Experimental Biology, November 29, 1977 
Hyland, William F., Attorney General, State of New Jersey, December 15. 
1977 
Lennette, Edwin H., President, Tissue Culture Association, November 30, 
1977 
Magee, P. T.. Chairman, Department of Microbiology and Public Health, 
Michigan State University, December 5. 1977 
Shapiro, James A., Department of Microbiology, University of Chicago, 
November 10, 1977 
Szybalski, Waelaw, Professor of Oncology, University of "Wisconsin, Janu- 
ary 4, 1978 
Goldstein. Richard, Department of Microbiology, Harvard University School 
of Medicine, to Donald Fredrickson, Director, National Institutes of 
Health, August 30, 1977 
Gorbach, Sherwood, Professor of Medicine and Microbiology, Tufts Univer- 
sity School of Medicine, to Donald Fredrickson, July 14, 1977 
Redys. John. Director, Laboratory Division, Department of Health. State 
of Connecticut, to Pamela Lippe, Friends of the Earth, November 7, 1977 
Sullivan. Clare D.. graduate student. Harvard School of Public Health, to 
Donald Fredrickson, December 29, 1977 
Executive Office of the President, 
; | Office of Science and Technology Policy. 
Washington, D.C., January 27, 197S. 
Hon. Adlai E. Stevenson, 
U.S. Senate, 
Washington, D.C. 
Dear Senator Stevenson : Thank you for your letter of November 29 and 
for the opportunity to testify before your Subcommittee on November 8 about 
recombinant DNA research and applications. 
You have raised searching questions about the appropriateness and usefulness 
of Section 361 of the Public Health Service Act as a basis for the issuance of 
regulations covering recombinant DNA activities. You are aware, I know, that 
the Department of HEW’s Office of General Counsel, which must rule on the 
applicability of Section 361, took the position a year ago that there are flaws in 
the use of Section 361. Most of the analysis of existing authorities, therefore, 
was directed at the Toxic Substances Control Act and the Occupational Safety 
and Health Act, as reported in the Interagency Report of March 15, 1977. The 
language of Section 361. dealing with “quarantine - ’ and with such communicable 
diseases as smallpox, cholera, yellow fever, and plague has certainly put off 
many policymakers and scientists. Dr. Omenn’s comments, to which you refer, 
do indeed reflect a concern that use of Section 361 might imply that the strictly 
speculative hazards associated with DNA research may be real. 
Since our November testimony, Dr. Omenn has looked into the background of 
the uses of Section 361, with the assistance of Mr. Peter Hutt, formerly Assistant 
General Counsel of HEW and Chief Counsel for the FDA. A copy of Mr. Hutt's 
detailed report is attached. It is clear that Section 361 has been utilized for a 
remarkable variety of relatively benign and even non-infeetious threats to the 
public health. Its applicability to the private sector and to intrastate activities 
has been established in Federal courts. Its applicability to effects on plants, 
animals, or other components of the general environment seems adequate, so 
long as there is any possibility of further transmission of effects to humans. 
Most important. Section 361 has been applied to practices and facilities such 
as shellfish beds, pet turtle production, importation of nonhuman primates, 
[Appendix B — 341] 
